MedTrace Logo

High-Flow-Therapy for the Treatment of Cheyne-Stokes-Respiration in Chronic Heart Failure

NCT03102827 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2018-09-26

No results posted yet for this study

Summary

To demonstrate the effectiveness and safety of nocturnal ventilation with oxygen (HFT - high-flow-therapy) for the treatment of CSA in patients with HFrEF compared to placebo (patient will breathe ambient air via nasal cannula that is not connected to the high-flow-device).

Conditions

  • Heart Failure，Congestive

Interventions

DRUG

Oxygen

Patients will receive oxygen with humidified air, fully saturated at 37° C at a flow rate of 20- 50 L/min. The ratio of oxygen and ambient air (FiO2) will be increased stepwise depending on patient's oxygen saturation.

OTHER

Placebo

Ambient air without high-flow therapy administered during first night

Sponsors & Collaborators

  • Heart and Diabetes Center North-Rhine Westfalia

    lead OTHER

Principal Investigators

  • Thomas Bitter, MD · Heart and Diabetes Center North Rhine-Westphalia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-02
Primary Completion
2018-03-27
Completion
2018-03-27

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03102827 on ClinicalTrials.gov